Blog & Resources Camargo Blog April 1st, 2009

FDA Stops DESI Unapproved Rx Narcotics

Yesterday, 3/31/09, FDA sent warning letters to nine pharmaceutical companies to stop manufacturing 14 unapproved narcotic drugs. These drugs are unapproved because they were made without NDA or ANDA approvals, falling under the category of DESI or grandfathered drugs.

Warning letters were sent to the following companies (I have listed the affected drug products for each company – note that the same 2 products are sold by 2 companies):

Glenmark Generics Inc. Morphine Sulfate Tablets, 15 mg & 30 mg Morphine Sulfate Solution Immediate Release Concentrate, 20 mg/ml Morphine Sulfate Solution Immediate Release Oral Solution, 20mg/5ml
Lannett Company, Inc. Morphine Sulfate Solution Immediate Release 20mg/ml Hydromorphone HCl Tablets, 2mg and 4mg
Lehigh Valley Technologies Inc. Morphine Sulfate Tablets, 15 mg & 30 mg; Morphine Sulfate Solution Concentrate, 20 mg/ml
Mallinckrodt Inc. Pharmaceuticals Group Morphine Sulfate Concentrate Oral Solution 20mg/ml
Xanodyne Pharmaceuticals Inc. **Roxanol Oral Solution, 20 mg/ml Roxicodone Tablets, 5 mg**
Physicians Total Care, Inc.Morphine Sulfate Immediate Release Tablets, 30 mg; Hydromorphone Tablets, 2 mg; Hydromorphone Hydrochloride Tablets 4 mg
Roxane Laboratories, Inc.Hydromorphone Hydrochloride Tablets, 2 mg & 4 mg
Boehringer Ingelheim Roxane Inc. **Roxanol Oral Solution, 20 mg/ml; Roxicodone Tablets, 5 mg**
Cody Laboratories, Inc. Morphine Sulfate Solution Immediate Release 20mg/ml

Camargo is engaged in a number of conversions of DESI to 505(b)(2) NDA’s. Clients are concerned that, once approved, the FDA would allow the unapproved competition to remain on the market. We believe actions such as this confirm that the FDA, once an NDA product is available, will take action. This latest action is a result of a program instituted in January 2007 ( summary here).

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